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Progestogen

Progesterone for Normal Puberty

Phase 1

Recruiting

Led By Christopher R McCartney, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Premenarcheal

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1100hr to 0700 hr

Awards & highlights

Study Summary

This trial is testing whether or not giving progesterone to pubertal girls will prevent the nighttime increase of LH pulses. If successful, this could help researchers understand more about how menstrual cycles are established.

Who is the study for?

This trial is for early to mid-puberty girls who haven't started their periods yet. They should have normal levels of certain hormones and no history of serious heart or lung problems, untreated thyroid issues, abnormally high testosterone or other hormone levels, low blood counts, or significant liver or kidney disease.Check my eligibility

What is being tested?

The study tests if small doses of progesterone can prevent an increase in luteinizing hormone (LH) pulses at night in pubertal girls. It also examines whether high testosterone affects progesterone's action on LH pulses. The goal is to understand how menstrual cycles normally start during puberty.See study design

What are the potential side effects?

Progesterone may cause mood swings, headaches, bloating, breast tenderness, and changes in sleep patterns or weight. These side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have not started menstruating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1100hr to 0700 hr

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1100hr to 0700 hr

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1100hr to 0700 hr for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average luteinizing hormone (LH) interpulse interval and the total number of LH pulses

Secondary outcome measures

Hourly hormone measurements during sampling period.

Side effects data

From 2018 Phase 4 trial • 64 Patients • NCT02255175

18%

Breast Tenderness

15%

Cramps

15%

Itchiness at patch site

12%

Headaches

Nausea

Acne

Lower Back Pain

Hot Flashes

Menstrual Bleeding

Bloating

Dizziness

100%

80%

60%

40%

20%

Study treatment Arm

Perimenopausal Women, Depressed

Perimenopausal Women, Non-depressed

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ProgesteroneExperimental Treatment1 Intervention

Subjects will take 5-25 mg oral micronized P (based on body weight, to achieve mean plasma P 1-2 ng/ml)

Group II: placeboPlacebo Group1 Intervention

placebo at 1100, 1500, and 1900 h.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Progesterone

2013

Completed Phase 4

~4510

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of VirginiaLead Sponsor

754 Previous Clinical Trials

1,245,033 Total Patients Enrolled

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,672,757 Total Patients Enrolled

Christopher R McCartney, MDPrincipal InvestigatorUniversity of Virginia

2 Previous Clinical Trials

162 Total Patients Enrolled

Media Library

Progesterone (Progestogen) Clinical Trial Eligibility Overview. Trial Name: NCT01428089 — Phase 1

Androgen Syndrome Research Study Groups: placebo, Progesterone

Androgen Syndrome Clinical Trial 2023: Progesterone Highlights & Side Effects. Trial Name: NCT01428089 — Phase 1

Progesterone (Progestogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01428089 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical maladies can Progesterone be employed to address?

"Progesterone is typically prescribed to treat uterine bleeding, but it also boasts efficacy in treating hormonal imbalances, recurrent premature labour prevention and endometrial hyperplasia caused by conjugated oestrogens."

Answered by AI

Does this research endeavor accept participants of age 20 or older?

"This clinical trial is exclusively recruiting patients aged between 7 and 14 years old. For those under 18, there are 27 studies available and 15 for individuals over 65."

Answered by AI

Are there any vacant positions for participants in this trial?

"As per information on clinicaltrials.gov, this trial is presently looking for participants. It was initially posted online on March 11th 2011 and the latest edit was made five days ago, i.e May 16th 2022."

Answered by AI

Has Progesterone been accepted by the FDA as a viable treatment?

"Our team at Power gave Progesterone a score of 1, since it is presently in the first phase of trials with limited data on its safety and efficacy."

Answered by AI

Who is the ideal candidate for enrollment in this clinical trial?

"To be eligible to join this research effort, patients should have a diagnosis of sclerocystic ovaries and fall within the age range of 7-14. The total number of participants needed is forty."

Answered by AI

How many participants can this research project accommodate?

"Affirmative. The clinical trial's page on the website provides evidence that recruitment of participants is ongoing, after its initial posting on March 11th 2011 and last update on May 16th 2022. This study needs to find 40 volunteers from a single site."

Answered by AI

Has there been precedent for research involving Progesterone?

"Presently, there are 42 Progesterone trials in progress with 8 of them being part of Phase 3. The bulk of these experiments are centred around Barcelona, Catalunya but the drug is being tested at a total 268 different locations worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone

Chris McCartney 2011. "Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01428089.

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